A Rapid Immunochromatographic Assay for Helicobacter pylori in Stool before and after Treatment

Background: Current guidelines recommend non-invasive testing and treatment of young dyspeptic patients without alarming symptoms. Aim: to evaluate the accuracy of a new rapid immunochromatographic stool test to diagnose Helicobacter pylori infection before and after treatment compared to a gold standard. Methods: Prospective, single blind study, performed in a tertiary care hospital. 303 consecutive dyspeptic patients underwent endoscopy with multiple biopsies. Infected patients were offered a treatment and invited to come back 4-6 weeks after the end of therapy to repeat the endoscopy. Patients were also asked to provide a stool sample before and after therapy. Results: 149 patients were H pylori infected. The sensitivity and specificity before treatment were 91.3% and 93.5%; after treatment 92% and 100%. The Likelihood Ratios (LRs) were robust enough to produce significant changes from pre-test to post-test probability both in pre treatment (LR +ve=14, LR-ve= 0.093) and post treatment (LR +ve= 19.6, LR-ve= 0.095). Conclusions: The novel immunochromatographic stool test is fast, easy to perform and provides good differentiation between positive and negative results. It might become a rapid near patients test easily performed in the physician office.